QA Engineer - PFT (12-Month Contract)

Medifox DAN GmbH; Johor Bahru; On-site; MYR 72,000 - 110,000; Full time

Job summary

Medifox DAN GmbH seeks a Quality Engineer to support manufacturing with quality objectives, risk-based planning and robust validation activities. You will contribute to continuous improvement of quality systems and ensure compliance with QMS and regulatory standards.

Responsibilities include supporting digital quality initiatives, problem solving, and collaboration across manufacturing, engineering and quality teams to deliver reliable product quality in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience with Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause/problem-solving methodologies.
• Ability to apply established Quality Engineering methods to support manufacturing quality delivery, investigations, validation, digital assurance/CSV/CSA deliverables.
• Independent and proactive learner, able to work under guidance of senior team members while building capability in digital quality, automation, advanced manufacturing, digital assurance and Quality by Design.
• Ability to use quality data and manufacturing information to identify trends, support decisions and recommend improvements.
• Good planning and organisational skills, with the ability to take initiative and ownership of assigned deliverables.
• Strong communication and collaboration skills, with the ability to build positive working relationships with manufacturing, engineering and quality partners.

Responsibilities

• Support quality objectives by applying Quality Engineering methods in manufacturing.
• Participate in new product/process introductions with QBD and risk-based planning.
• Support readiness activities including validation deliverables and control strategy.
• Apply QA standards to drive consistency and standardization across manufacturing teams.
• Use quality data to identify trends and support investigations.
• Contribute to continuous improvement of quality systems and practices.
• Provide quality guidance through training and coaching.
• Partner with functions to ensure Quality requirements early in changes.
• Support digital quality pilots and engage CSV/CSA experts.
• Foster a quality culture across manufacturing and partners.
• Ensure compliance to QMS and regulatory standards.
• Perform internal/external audits as required.

Skills

Quality Systems

Manufacturing Quality

Risk Management

Process Validation

Root Cause Analysis

Quality by Design

Digital Quality

Automation

Digital Assurance

Quality Planning

Data-driven decision making

Communication & Collaboration

Education

Bachelor’s degree in Engineering or Science

Tools

AI tools

MES

CSV/CSA

Job description

Let's talk about Responsibilities

• Support Manufacturing to achieve Quality, Availability and Value objectives by applying established Quality Engineering methods and contributing to reliable manufacturing quality performance.
• Participate in and support new product, process, technology and manufacturing capability introduction, applying Quality by Design, risk-based quality planning and appropriate quality controls through XFT deliverables and phase transitions.
• Support manufacturing readiness activities, including quality planning, risk assessments, validation activities, digital assurance/CSV/CSA deliverables where applicable, control strategy execution and launch/post-launch learning.
• Apply established Manufacturing QA standards, methods, playbooks and tools to support consistency, standardization and adoption of proven approaches across manufacturing teams.
• Use quality and manufacturing data, including NCP/CAPA learning, validation outputs, audit findings and process performance signals, to identify trends, support investigations, recommend preventive actions and contribute learning to future Quality Engineering solutions.
• Contribute to continuous improvement of manufacturing quality systems, processes and engineering practices, supporting improved Right First Time performance and reduction of repeat or systemic quality issues.
• Provide quality / technical guidance through training, consultation and coaching, building capability in structured problem solving, risk management, process validation, digital assurance awareness and data-driven decision making.
• Partner with Manufacturing Engineering, Operations and other functions to ensure Quality requirements are considered early in process, equipment, technology, automation, MES and digital manufacturing changes.
• Participate in digital quality, automation, advanced manufacturing or transformation pilots where required, supporting development, testing and operational adoption of new quality capabilities and engaging specialist CSV/CSA expertise where applicable.
• Foster a quality culture through education, consultation and day-to-day engagement with manufacturing and cross-functional partners.
• Ensure risks of non-compliance and related business risks are identified, assessed and mitigated with support from senior team members where required.
• Ensure compliance to the ResMed QMS and applicable regulatory standards.
• Perform or support internal, external and supplier audits as required.

Let's talk about Qualifications and Experience

Required

• Bachelor's degree in Engineering or Science with at least 3 years' experience in a regulated volume manufacturing industry.
• Experience or exposure in Quality Systems, Manufacturing Quality, risk management, process validation and structured root cause/problem-solving methodologies.
• Ability to apply established Quality Engineering methods to support manufacturing quality delivery, investigations, validation, digital assurance/CSV/CSA deliverables where applicable, quality planning and improvement activities.
• Independent and proactive learner, able to work under guidance of senior team members while building capability in digital quality, automation, advanced manufacturing, digital assurance and Quality by Design.
• Ability to use quality data and manufacturing information to identify trends, support decisions and recommend improvements.
• Good planning and organisational skills, with the ability to take initiative and ownership of assigned deliverables.
• Strong communication and collaboration skills, with the ability to build positive working relationships with manufacturing, engineering and quality partners.

Preferred

• Experience in Quality and/or Regulatory positions in the medical device industry.
• Experience in Quality Systems, Manufacturing Quality, process validation and risk management methodologies.
• Demonstrated capability in using AI tools or data-driven technologies for efficiency improvement, quality insights and decision support.
• Exposure to MES/digital quality, CSV/Computer Software Assurance (CSA), automation, advanced analytics, Quality by Design or advanced quality planning.
• Exposure to manufacturing readiness, new product introduction, process technology changes, equipment changes, validation activities or software-enabled manufacturing systems in a regulated environment.
• Interest in developing toward senior technical Quality Engineering contribution across manufacturing quality, automation, digital quality, risk-based digital assurance and proactive assurance.

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Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.